CELL GEN LASER, MODEL CG-4000


Device Classification Name

lamp, infrared, therapeutic heating

510(k) Number K080084
Device Name CELL GEN LASER, MODEL CG-4000
Applicant
CELL GEN THERAPEUTICS, LLC
17734 preston road
suite 204
dallas, 
TX 
75252

Applicant Contact dick rivera
Correspondent
CELL GEN THERAPEUTICS, LLC
17734 preston road
suite 204
dallas, 
TX 
75252

Correspodent Contact dick rivera
Regulation Number 890.5500
Classification Product Code
ILY  
Date Received 01/11/2008
Decision Date 04/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No